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Senior Supplier Quality Engineer

Job description

Our client, a leading medical device company based here in Galway is looking for a Supplier Quality Engineer to join their team on a 12-month contract.

In this role you would be working with external suppliers as well as within a cross functional team to resolve supplier related issues. This person would be a driving continuous improvement while also driving key quality metrics across the Galway location.

Responsibilities.

  • Communicate with management and project team about supplier performance.
  • Support in review of supplier introduction and changes, coordinating activities with suppliers as well as cross functional teams to develop and implement appropriate strategies to qualify and support.
  • Provide expert QE technical direction input to component qualification strategies.
  • Ensure appropriate controls are in place at supplier based on risk associated with product or service.
  • Develop and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure GMP and quality standards are met.
  • Define receiving inspection requirements as required and associated test method validation for all internal test methods.

Experience.

  • Bachelor’s Degree in a relevant technical discipline such as Engineering or Science or another technical field.
  • Minimum 5 years relevant experience.
  • The ideal candidate is a team player with excellent communication skills both verbal and written.
  • Knowledge of regulatory requirements and guidelines including 21 CFR parts 210,211, 21 CFR part 820, ICH requirements and ISO 13485 is an advantage.
  • Previous experience in Supplier Quality would be an advantage.
  • ISO 13485 Lead Auditor Certification would be an advantage.

 

If you would like to discuss this role, reach out to Rebecca O'Connor on 091 749265 or email roconnor@sigmar.ie

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